Lung CancerNCT02734069
Impact of Fat-free Mass in the Carboplatin Calculated Dose and Chemotherapeutic Toxicity in Patients With Advanced NSCLC
An observational study of Lung Cancer and Sarcopenia, run by Instituto Nacional de Cancerologia de Mexico at 1 site in Mexico.
Trial summary
This study evaluate the association of body composition (mainly free-fat mass), clinical and biochemical parameters with development of toxicity in patients under treatment with Carboplatin/Paclitaxel in advanced NSCLC. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Sarcopenia, Toxicity
- What is being tested?
- Carboplatin
- How many people
- 132 participants
- Where
- 1 siteMexico
- Study dates
- Feb 2016to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with advanced NSCLC, as candidates for the first line chemotherapy regimen of carboplatin / paclitaxel or Carboplatin / Pemetrexed
Who may be able to join
- Diagnosis of NSCLC Stage IV (stratification according to the American Joint Committee on Cancers - 7th edition)
- Candidates for treatment with carboplatin plus paclitaxel 1st line
- Performance status (ECOG 0-2)
- Laboratory studies that demonstrate adequate renal, hepatic and hematologic function (blood chemistry and blood count)
- Normal renal ultrasound prior to initiation of treatment
Who cannot join
- Patients with renal impairment (KDOQI 3-5)
- Patients who do not have computed tomography study at baseline
- Uncontrolled blood pressure (> 140 mmHg)
- Uncontrolled diabetes (> 130 mg / dL)
- Obstruction in kidney (s) or ureter (s)
- Dehydrated patients
- Patients with high consumption of NSAIDs (aspirin, ibuprofen, etc.> 1 month)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mexico1 site, 1 recruiting
- Recruiting
Instituto Nacional de Cancerologia
Mexico City, 14080
Oscar Arrieta, 015556280400
About this study
Official title: Impact of Fat-free Mass in the Carboplatin Calculated Dose and Chemotherapeutic Toxicity in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)
This study evaluate the association of body composition (mainly free-fat mass), clinical and biochemical parameters with development of toxicity in patients under treatment with Carboplatin/Paclitaxel in advanced NSCLC.
Read the detailed description
BACKGROUND
Lung cancer (LC) is the leading cause of cancer deaths worldwide, are attributed about 13% of all new cases of cancer and accounts for 19.4% of deaths from malignancies. In Mexico, this cancer is also the leading cause of death in malignant neoplasias. One of the reasons attributable the high mortality from this disease is that most cases are detected in advanced stages and this depends prognosis and treatment. Within the classification of LC the most prevalent is the Non Small Cell Lung Cancer (NSCLC); for which the considered first-line standard treatment is palliative cytotoxic chemotherapy, as the combination of carboplatin with paclitaxel and in the other hand one of the most recent combinations Carboplatin with Pemetrexed.
Malnutrition may affect 80% of patients with advanced cancer and is associated with up to 20% of deaths, with an increased risk in the development of complications and mortality and can extend the hospital stay up to 90%, increasing the cost of treatment in a 35-75%. Similarly, in a previous study at INCan, the degree of malnutrition in patients with LC was associated with cytotoxic chemotherapy toxicity and poorer prognosis and poorer quality of life. Sarcopenia is also a phenomenon commonly observed in patients with LC, there has been a prevalence of 61% and 31% in men and women respectively.
Carboplatin dose that is administered to the patient is calculated by the Calvert formula, this requires the calculation of glomerular filtration rate (GFR). There are various quantified and estimated methods to calculate GFR; however the validated and most commonly used is estimated by the Cockroft-Gault formulae. It is known that due to various factors, variables required for calculation (as creatinine) could be modify the result, may became unreliable, it is why it is important to consider changes in body composition of NSCLC patients with sarcopenia.
HYPOTHESIS:
Sarcopenia participants receive a 20% more dose of Carboplatin per Free Fat Mass (kg / mg) than those without sarcopenia.
Sarcopenic patients, have more severe toxicity related to chemotherapy than those without sarcopenia.
METHODOLOGY:
NSCLC patients with advanced NSCLC (inoperable stage III or IV ) will be included.
Clinicopathological baseline of patients such as age, sex, stage, ECOG, weight, height, body composition, Subjective Global Assessment, frequency of food consumption, albumin, hemoglobin, hematocrit, glomerular filtration rate, carboplatin administered dosage, quality of life, etc.
A subsequent follow-up evaluation will be made after 1st and 2nd cycle of treatment to assess toxicity.
- Conditions
- Lung Cancer, Sarcopenia, Toxicity
- Being tested
- Carboplatin
- Keywords
- carboplatin
- Medical subject headings
- Lung Neoplasms, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CarboplatinDrug
Also called CARBOPLAT
Patients will receive carboplatin according to the carboplatin area under the curve dose calculation for 2 cycles to evaluate toxicity.
| Study group | Role | What they receive |
|---|---|---|
| Sarcopenic | Patients with sarcopenia (evaluated according to CT scans) will be followed up through treatment with carboplatin for identification of any toxicity grade 3 or 4 (Common Terminology Criteria of Adverse Events) Receives: Drug: Carboplatin | |
| Non Sarcopenic | Patients without sarcopenia (evaluated according to CT scans) will be followed up through treatment with carboplatin for identification of any toxicity grade 3 or 4 (Common Terminology Criteria of Adverse Events) Receives: Drug: Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Determine if the dose of carboplatin-based chemotherapy in patients according to the amount of fat-free mass is directly associated with toxicity
Measured: Three weeks after the application of chemotherapy to detect changes from Baseline
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Determine if the dose of carboplatin-based chemotherapy in patients according to the amount of fat-free mass is directly associated with toxicity
Measured: Six weeks after the application of chemotherapy to detect changes from Baseline
Secondary outcomes (1)
Compare different formulas to calculate Glomerular Filtration Rate taking as gold standard cystatin c
Calculate the glomerular filtration rate given the amount of fat-free mass (MSA-eCrCl) and correlate with cystatin C and formulas as Cockroft-Gault, Levey, The Modification of Diet in Renal Disease (MDRD) and Chronic kidney disease epidemiology collaboration (CKD-EPI).
Measured: Basal evaluation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2016 (estimated)
- Study startFeb 2016
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Cancerologia de Mexico
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oscar Gerardo Arrieta Rodríguez, Instituto Nacional de Cancerologia de Mexico
- Investigators
- Oscar Arrieta, MD, MSc, Principal investigator, Instituto Nacional de Cancerologia, Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02734069
- Sponsor's protocol ID
- INCAN/TOX/CBP
- Status last verified
- Dec 2025
- First submitted
- 31 Mar 2016
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Ferlay J, Soerjomataram I, Dikshit R, Eser S, Mathers C, Rebelo M, Parkin DM, Forman D, Bray F. Cancer incidence and mortality worldwide: sources, methods and major patterns in GLOBOCAN 2012. Int J Cancer. 2015 Mar 1;136(5):E359-86. doi: 10.1002/ijc.29210. Epub 2014 Oct 9.
PubMed 25220842Ruiz-Godoy L, Rizo Rios P, Sanchez Cervantes F, Osornio-Vargas A, Garcia-Cuellar C, Meneses Garcia A. Mortality due to lung cancer in Mexico. Lung Cancer. 2007 Nov;58(2):184-90. doi: 10.1016/j.lungcan.2007.06.007. Epub 2007 Jul 30.
PubMed 17659812Cullen MH, Billingham LJ, Woodroffe CM, Chetiyawardana AD, Gower NH, Joshi R, Ferry DR, Rudd RM, Spiro SG, Cook JE, Trask C, Bessell E, Connolly CK, Tobias J, Souhami RL. Mitomycin, ifosfamide, and cisplatin in unresectable non-small-cell lung cancer: effects on survival and quality of life. J Clin Oncol. 1999 Oct;17(10):3188-94. doi: 10.1200/JCO.1999.17.10.3188.
PubMed 10506617Schiller JH, Harrington D, Belani CP, Langer C, Sandler A, Krook J, Zhu J, Johnson DH; Eastern Cooperative Oncology Group. Comparison of four chemotherapy regimens for advanced non-small-cell lung cancer. N Engl J Med. 2002 Jan 10;346(2):92-8. doi: 10.1056/NEJMoa011954.
PubMed 11784875Gronberg BH, Bremnes RM, Flotten O, Amundsen T, Brunsvig PF, Hjelde HH, Kaasa S, von Plessen C, Stornes F, Tollali T, Wammer F, Aasebo U, Sundstrom S. Phase III study by the Norwegian lung cancer study group: pemetrexed plus carboplatin compared with gemcitabine plus carboplatin as first-line chemotherapy in advanced non-small-cell lung cancer. J Clin Oncol. 2009 Jul 1;27(19):3217-24. doi: 10.1200/JCO.2008.20.9114. Epub 2009 May 11.
PubMed 19433683Gordon JN, Green SR, Goggin PM. Cancer cachexia. QJM. 2005 Nov;98(11):779-88. doi: 10.1093/qjmed/hci127. Epub 2005 Oct 7.
PubMed 16214835Ottery FD. Cancer cachexia: prevention, early diagnosis, and management. Cancer Pract. 1994 Mar-Apr;2(2):123-31.
PubMed 8055014Muscaritoli M, Bossola M, Aversa Z, Bellantone R, Rossi Fanelli F. Prevention and treatment of cancer cachexia: new insights into an old problem. Eur J Cancer. 2006 Jan;42(1):31-41. doi: 10.1016/j.ejca.2005.07.026. Epub 2005 Nov 28.
PubMed 16314085Sanchez-Lara K, Turcott JG, Juarez E, Guevara P, Nunez-Valencia C, Onate-Ocana LF, Flores D, Arrieta O. Association of nutrition parameters including bioelectrical impedance and systemic inflammatory response with quality of life and prognosis in patients with advanced non-small-cell lung cancer: a prospective study. Nutr Cancer. 2012;64(4):526-34. doi: 10.1080/01635581.2012.668744. Epub 2012 Apr 10.
PubMed 22489794Baracos VE, Reiman T, Mourtzakis M, Gioulbasanis I, Antoun S. Body composition in patients with non-small cell lung cancer: a contemporary view of cancer cachexia with the use of computed tomography image analysis. Am J Clin Nutr. 2010 Apr;91(4):1133S-1137S. doi: 10.3945/ajcn.2010.28608C. Epub 2010 Feb 17.
PubMed 20164322Calvert AH, Newell DR, Gumbrell LA, O'Reilly S, Burnell M, Boxall FE, Siddik ZH, Judson IR, Gore ME, Wiltshaw E. Carboplatin dosage: prospective evaluation of a simple formula based on renal function. J Clin Oncol. 1989 Nov;7(11):1748-56. doi: 10.1200/JCO.1989.7.11.1748.
PubMed 2681557Nannan Panday VR, van Warmerdam LJ, Huizing MT, Ten Bokkel Huinink WW, Vermorken JB, Giaccone G, Veenhof CH, Schellens JH, Beijnen JH. Carboplatin dosage formulae can generate inaccurate predictions of Carboplatin exposure in carboplatin/paclitaxel combination regimens. Clin Drug Investig. 1998;15(4):327-35. doi: 10.2165/00044011-199815040-00009.
PubMed 18370488Hudson JQ, Owens HM, Fleckenstein JF, Loveless VS, Krauss AG, Hak LJ. Performance of methods to assess kidney function in a predominantly overweight sample of patients with liver disease. Ren Fail. 2013;35(2):249-56. doi: 10.3109/0886022X.2012.745786. Epub 2012 Nov 26.
PubMed 23176438Cockcroft DW, Gault MH. Prediction of creatinine clearance from serum creatinine. Nephron. 1976;16(1):31-41. doi: 10.1159/000180580.
PubMed 1244564Botev R, Mallie JP, Wetzels JF, Couchoud C, Schuck O. The clinician and estimation of glomerular filtration rate by creatinine-based formulas: current limitations and quo vadis. Clin J Am Soc Nephrol. 2011 Apr;6(4):937-50. doi: 10.2215/CJN.09241010. Epub 2011 Mar 31.
PubMed 21454722
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Fat-free Mass in the Carboplatin Calculated Dose and Chemotherapeutic Toxicity in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)
- ClinicalTrials.gov ID
- NCT02734069
- Acronym / sponsor ID
- INCAN/TOX/CBP
- Conditions
- Lung Cancer, Sarcopenia, Toxicity
- Keywords
- carboplatin
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Instituto Nacional de Cancerologia de MexicoUniversity, hospital or other
- Study start
- Feb 2016 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 12 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluate the association of body composition (mainly free-fat mass), clinical and biochemical parameters with development of toxicity in patients under treatment with Carboplatin/Paclitaxel in advanced NSCLC.
Detailed description
BACKGROUND
Lung cancer (LC) is the leading cause of cancer deaths worldwide, are attributed about 13% of all new cases of cancer and accounts for 19.4% of deaths from malignancies. In Mexico, this cancer is also the leading cause of death in malignant neoplasias. One of the reasons attributable the high mortality from this disease is that most cases are detected in advanced stages and this depends prognosis and treatment. Within the classification of LC the most prevalent is the Non Small Cell Lung Cancer (NSCLC); for which the considered first-line standard treatment is palliative cytotoxic chemotherapy, as the combination of carboplatin with paclitaxel and in the other hand one of the most recent combinations Carboplatin with Pemetrexed.
Malnutrition may affect 80% of patients with advanced cancer and is associated with up to 20% of deaths, with an increased risk in the development of complications and mortality and can extend the hospital stay up to 90%, increasing the cost of treatment in a 35-75%. Similarly, in a previous study at INCan, the degree of malnutrition in patients with LC was associated with cytotoxic chemotherapy toxicity and poorer prognosis and poorer quality of life. Sarcopenia is also a phenomenon commonly observed in patients with LC, there has been a prevalence of 61% and 31% in men and women respectively.
Carboplatin dose that is administered to the patient is calculated by the Calvert formula, this requires the calculation of glomerular filtration rate (GFR). There are various quantified and estimated methods to calculate GFR; however the validated and most commonly used is estimated by the Cockroft-Gault formulae. It is known that due to various factors, variables required for calculation (as creatinine) could be modify the result, may became unreliable, it is why it is important to consider changes in body composition of NSCLC patients with sarcopenia.
HYPOTHESIS:
Sarcopenia participants receive a 20% more dose of Carboplatin per Free Fat Mass (kg / mg) than those without sarcopenia.
Sarcopenic patients, have more severe toxicity related to chemotherapy than those without sarcopenia.
METHODOLOGY:
NSCLC patients with advanced NSCLC (inoperable stage III or IV ) will be included.
Clinicopathological baseline of patients such as age, sex, stage, ECOG, weight, height, body composition, Subjective Global Assessment, frequency of food consumption, albumin, hemoglobin, hematocrit, glomerular filtration rate, carboplatin administered dosage, quality of life, etc.
A subsequent follow-up evaluation will be made after 1st and 2nd cycle of treatment to assess toxicity.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sarcopenic | – | Drug: CarboplatinPatients with sarcopenia (evaluated according to CT scans) will be followed up through treatment with carboplatin for identification of any toxicity grade 3 or 4 (Common Terminology Criteria of Adverse Events) |
| Non Sarcopenic | – | Drug: CarboplatinPatients without sarcopenia (evaluated according to CT scans) will be followed up through treatment with carboplatin for identification of any toxicity grade 3 or 4 (Common Terminology Criteria of Adverse Events) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with advanced NSCLC, as candidates for the first line chemotherapy regimen of carboplatin / paclitaxel or Carboplatin / Pemetrexed
Key inclusion criteria (5 listed)
- Diagnosis of NSCLC Stage IV (stratification according to the American Joint Committee on Cancers - 7th edition)
- Candidates for treatment with carboplatin plus paclitaxel 1st line
- Performance status (ECOG 0-2)
- Laboratory studies that demonstrate adequate renal, hepatic and hematologic function (blood chemistry and blood count)
- Normal renal ultrasound prior to initiation of treatment
Key exclusion criteria (7 listed)
- Patients with renal impairment (KDOQI 3-5)
- Patients who do not have computed tomography study at baseline
- Uncontrolled blood pressure (> 140 mmHg)
- Uncontrolled diabetes (> 130 mg / dL)
- Obstruction in kidney (s) or ureter (s)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CarboplatinAlso: CARBOPLATPatients will receive carboplatin according to the carboplatin area under the curve dose calculation for 2 cycles to evaluate toxicity. | Drug | Non Sarcopenic, Sarcopenic |
Primary outcome
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: Three weeks after the application of chemotherapy to detect changes from Baseline
Determine if the dose of carboplatin-based chemotherapy in patients according to the amount of fat-free mass is directly associated with toxicity
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: Six weeks after the application of chemotherapy to detect changes from Baseline
Determine if the dose of carboplatin-based chemotherapy in patients according to the amount of fat-free mass is directly associated with toxicity
1 secondary outcome
Compare different formulas to calculate Glomerular Filtration Rate taking as gold standard cystatin c
Time frame: Basal evaluation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2025.
- Background: PubMed 25220842Ferlay J, Soerjomataram I, Dikshit R, Eser S, Mathers C, Rebelo M, Parkin DM, Forman D, Bray F. Cancer incidence and mortality worldwide: sources, methods and major patterns in GLOBOCAN 2012. Int J Cancer. 2015 Mar 1;136(5):E359-86. doi: 10.1002/ijc.29210. Epub 2014 Oct 9.
- Background: PubMed 17659812Ruiz-Godoy L, Rizo Rios P, Sanchez Cervantes F, Osornio-Vargas A, Garcia-Cuellar C, Meneses Garcia A. Mortality due to lung cancer in Mexico. Lung Cancer. 2007 Nov;58(2):184-90. doi: 10.1016/j.lungcan.2007.06.007. Epub 2007 Jul 30.
- Background: PubMed 10506617Cullen MH, Billingham LJ, Woodroffe CM, Chetiyawardana AD, Gower NH, Joshi R, Ferry DR, Rudd RM, Spiro SG, Cook JE, Trask C, Bessell E, Connolly CK, Tobias J, Souhami RL. Mitomycin, ifosfamide, and cisplatin in unresectable non-small-cell lung cancer: effects on survival and quality of life. J Clin Oncol. 1999 Oct;17(10):3188-94. doi: 10.1200/JCO.1999.17.10.3188.
- Background: PubMed 11784875Schiller JH, Harrington D, Belani CP, Langer C, Sandler A, Krook J, Zhu J, Johnson DH; Eastern Cooperative Oncology Group. Comparison of four chemotherapy regimens for advanced non-small-cell lung cancer. N Engl J Med. 2002 Jan 10;346(2):92-8. doi: 10.1056/NEJMoa011954.
- Background: PubMed 19433683Gronberg BH, Bremnes RM, Flotten O, Amundsen T, Brunsvig PF, Hjelde HH, Kaasa S, von Plessen C, Stornes F, Tollali T, Wammer F, Aasebo U, Sundstrom S. Phase III study by the Norwegian lung cancer study group: pemetrexed plus carboplatin compared with gemcitabine plus carboplatin as first-line chemotherapy in advanced non-small-cell lung cancer. J Clin Oncol. 2009 Jul 1;27(19):3217-24. doi: 10.1200/JCO.2008.20.9114. Epub 2009 May 11.
- Background: PubMed 16214835Gordon JN, Green SR, Goggin PM. Cancer cachexia. QJM. 2005 Nov;98(11):779-88. doi: 10.1093/qjmed/hci127. Epub 2005 Oct 7.
- Background: PubMed 8055014Ottery FD. Cancer cachexia: prevention, early diagnosis, and management. Cancer Pract. 1994 Mar-Apr;2(2):123-31.
- Background: PubMed 16314085Muscaritoli M, Bossola M, Aversa Z, Bellantone R, Rossi Fanelli F. Prevention and treatment of cancer cachexia: new insights into an old problem. Eur J Cancer. 2006 Jan;42(1):31-41. doi: 10.1016/j.ejca.2005.07.026. Epub 2005 Nov 28.
- Background: PubMed 22489794Sanchez-Lara K, Turcott JG, Juarez E, Guevara P, Nunez-Valencia C, Onate-Ocana LF, Flores D, Arrieta O. Association of nutrition parameters including bioelectrical impedance and systemic inflammatory response with quality of life and prognosis in patients with advanced non-small-cell lung cancer: a prospective study. Nutr Cancer. 2012;64(4):526-34. doi: 10.1080/01635581.2012.668744. Epub 2012 Apr 10.
- Background: PubMed 20164322Baracos VE, Reiman T, Mourtzakis M, Gioulbasanis I, Antoun S. Body composition in patients with non-small cell lung cancer: a contemporary view of cancer cachexia with the use of computed tomography image analysis. Am J Clin Nutr. 2010 Apr;91(4):1133S-1137S. doi: 10.3945/ajcn.2010.28608C. Epub 2010 Feb 17.
- Background: PubMed 2681557Calvert AH, Newell DR, Gumbrell LA, O'Reilly S, Burnell M, Boxall FE, Siddik ZH, Judson IR, Gore ME, Wiltshaw E. Carboplatin dosage: prospective evaluation of a simple formula based on renal function. J Clin Oncol. 1989 Nov;7(11):1748-56. doi: 10.1200/JCO.1989.7.11.1748.
- Background: PubMed 18370488Nannan Panday VR, van Warmerdam LJ, Huizing MT, Ten Bokkel Huinink WW, Vermorken JB, Giaccone G, Veenhof CH, Schellens JH, Beijnen JH. Carboplatin dosage formulae can generate inaccurate predictions of Carboplatin exposure in carboplatin/paclitaxel combination regimens. Clin Drug Investig. 1998;15(4):327-35. doi: 10.2165/00044011-199815040-00009.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Oscar Arrieta, MD, MSc principal investigator
Instituto Nacional de Cancerologia, Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer and Sarcopenia, run by Instituto Nacional de Cancerologia de Mexico at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Oscar Arrieta, MD, M Sc (015556280400 ext. 44001, ogar@unam.mx), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 (time frame: Three weeks after the application of chemotherapy to detect changes from Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02734069, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2025.